A Dose Escalation Phase I Clinical Study to Evaluate the Tolerability and Safety of IBI302 in Patients With Neovascular Age-related Macular Degeneration (nAMD)

Innovent Biologics (Suzhou) Co. Ltd.1 site in 1 country18 target enrollmentMay 28, 2020

ConditionsNeovascular Age-related Macular Degeneration

InterventionsIBI302 (the first dose level)IBI302 (the second dose level)Aflibercept

DrugsIBI302 (the first dose level)IBI302 (the second dose level)Aflibercept

Overview

Phase: Phase 1
Intervention: IBI302 (the first dose level)
Conditions: Neovascular Age-related Macular Degeneration
Sponsor: Innovent Biologics (Suzhou) Co. Ltd.
Enrollment: 18
Locations: 1
Primary Endpoint: Ocular safety, assessed by BCVA, slitlamp examination, ophthalmoscopy, IOP, fundus photography
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This study is designed for multi-center, open-label, randomized, dose escalation phase I trial to evaluate the safety and tolerability of a multiple dose intravitreal injection of IBI302 in neovascular AMD patients.

Registry

clinicaltrials.gov

Start Date

May 28, 2020

End Date

May 8, 2021

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Innovent Biologics (Suzhou) Co. Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Inclusion criteria
•Male or female patient ≥ 50 yrs. of age.
•Active subfoveal or parafoveal CNV secondary to neovascular AMD.
•Willing and able to sign informed consent form and comply with visit and study procedures per protocol.
•Exclusion criteria
•Presence of uncontrolled glaucoma in the study eye (defined as IOP≥30mmHg despite the standardized treatment);
•Presence of active intraocular or periocular inflammation or infection;
•History of severe hypersensitivity/allergy to active ingredients or any excipients of the study drug, or fluorescein and povidone iodine;
•Participated in any clinical study of any other drug within three months prior to enrollment, or attempted to participate in other drug trials during the study;
•Diabetic patients have any of the following conditions:HbA1c\>7.5% when screening;

Exclusion Criteria

Not provided

Arms & Interventions

low dose of IBI302

Intervention: IBI302 (the first dose level)

high dose of IBI302

Intervention: IBI302 (the second dose level)

2mg aflibercept

Intervention: Aflibercept

Outcomes

Primary Outcomes

Ocular safety, assessed by BCVA, slitlamp examination, ophthalmoscopy, IOP, fundus photography

Time Frame: Baseline to Day140

Incidence of adverse events

Time Frame: Baseline to Day140

Secondary Outcomes

Changes in central subfield thickness by OCT compared with baseline(Baseline to Day140)
Changes in CNV characteristics and CNV area by FA compared with baseline(Baseline to Day140)
Changes in BCVA compared with baseline(Baseline to Day140)
the area under the curve at the time of 0-infinity of IBI302(Baseline to Day140)
Positive rate of anti-drug antibody and neutralizing antibody of IBI302(Baseline to Day140)
the area under the drug-time curve from 0 to time t of IBI302(Baseline to Day140)
The peak concentration of IBI302(Baseline to Day140)
The peak time of IBI302(Baseline to Day140)
Clearance rate of IBI302(Baseline to Day140)
Half-life of IBI302(Baseline to Day140)
VEGF concentration(Baseline to Day140)
Concentration of complement fragments(Baseline to Day140)